ISO 14971 Risk Management and Assurance Case
QMSpace™ Design Controls: All in One Solution for Design Controls

- Intuitive traceability among needs, requirements, specifications, test cases results 

- Tabular, graphic and narrative editors, and Export to html, word or PDF

- Automatic linking to risk management and safety assurance cases 

- Design History File (DHF) Management (Plans, Reports etc.)

- Life cycle change management

ISO 14971 Risk Management
QMSpace™ Risk Management: All in One Global Risk Management Solution
- All in one Electronic Risk Management File in compliance with standards and regulations (e.g. ISO 14971, ISO 13485 and FDA requirements)
- Support  multiple risks (safety, performance, cybersecurity, business etc.) and multiple sets (for different business units, product lines etc.)
- Highly configurable Templates for Hazard Analysis / Risk Assessment, Failure Mode and Effects Analysis (dFMEA, uFMEA and pFMEA) with results automatically linked
- Built-in toolkit for Fault Tree Analysis (FTA) with reliability calculation and automatic linking with the risk analysis results
- Multi Analytical Reports - Risk Heat Map, Interaction Maps, Checklists etc.
Part 11 Compliant Electronic records and signatures
- Plug ins and APIs for connectivity with other requirement management tools 
security-risk-safety-risk.png
QMSpace™ Cybersecurity: All in One Global Cybersecurity Risk Management Solution
- All in one Electronic Cybersecurity Risk Management File in compliance with standards and regulations
- Highly configurable Templates for Asset Profiling, Threat Modeling / Attack Tree Analysis, Vulnerability Analysis, Security Control Measures, Cybersecurity Risk Assessment and Summary etc.
- Automatic connectivity with Safety Risk Management
- Multi Analytical Reports - Risk Heat Map, Standard based Checklists etc.
Part 11 Compliant Electronic records and signatures
- Life Cycle Cybersecurity Risk Management
ISO 14971 Safety Assurance Case
QMSpace™ Assurance Cases:  All in One Assurance Case Development Solution

 

- Tabular, graphic, and narractive safety assurance case editors

​- Able to convert the tabular or XML format safety assurance case into graphic HTML file that can be viewed and navigated using a web browser

​- Able to convert existing risk management information into a safety assurance case table or graphic

​- Integration of risk management and safety assurance case throughout the product life cycle

​- Intuitively guiding for additional information that is needed for a robust safety assurance case

​- Electronic submission of safety assurance cases to the FDA